Senior Director, Product Development Clinical Lead (Gastroenterology Indications)

    • Spring House, PA

The Senior Director, Product Development Clinical Leader (PDCL) role is responsible and accountable for the oversight of the Scientific and Clinical Development strategy across indications for assigned Compound Development Team (CDT) asset(s) at Janssen. This position is a Core member of the Compound Development Team (CDT). In collaboration with key CDT functions, including Translational Medicine, Late Phase Clinical Development, GCSO, and other key functions, the PDCL is accountable for developing the overall clinical development strategy for assigned programs, including oversight of the design, implementation and reporting of programs in targeted disease states. The successful candidate will have exceptional clinical development, preferably with experience working on GI diseases, the ability to think strategically about drug development, direct and indirect-leadership and communications skills as well as a high degree of curiosity, innovation, entrepreneurship and a keen sense of patient unmet need.

Primary Responsibilities
• Membership on the Core and Extended Compound Development Teams, Core Membership on the Safety Management Team and other product oversight teams as the molecule responsible physician (MRP).
• Accountable for strategic clinical program reviews in the broader Janssen R&D structure, and overall strategy and execution of clinical development programs through product licensing.
• Collaborate with Disease Area Strongholds (DASs), Pathway Strongholds (PASs), and both Core and Extended CDT functions including Translational Science and Medicine, Late Clinical Development, Discovery, Clinical Pharmacology, Medical Affairs and Commercial, and Business Development/Alliance Management to develop and oversee delivery of a comprehensive clinical development strategy.
• Indirectly lead a team of physicians and scientists who design, implement and report out early and late-stage clinical trials in disease targets delivering to the compound/product strategy.
• Accountable for oversight and strategic direction of clinical portions of regulatory submissions, including licensing applications and other regulatory submissions.
• Deliver innovative, fit-for-purpose and transformational development strategies that address high unmet need for the CDT asset(s). This includes next-generation combination regimens to achieve transformative levels of efficacy.

General Leadership Expectations
• Effective collaboration and implementation of core Immunology TA strategies with a one-team, one-portfolio mindset
• Strong capacity to work in a matrix environment, leading directly and indirectly
• Ability to lead through delegation and work collaboratively across diverse teams
• Outstanding visionary, strategic, communication and entrepreneurial skills
• Develop and maintain a strong external network including credible relationships with scientific leaders, key clinical opinion leaders, and regulatory officials as needed to advance the Immunology portfolio.
• Develop and maintain strong internal network with cross-functional groups required to operationalize and drive portfolio progression
• Represent both Janssen and the Immunology TA in a professional manner internally and externally

Qualifications
• MD or MD/PhD is required.
• At least 10 years of relevant experience in drug development or equivalent. Extensive clinical development experience, with preference given to development experience in GI diseases. Experience working on external alliance programs also desirable.
• Candidates should possess significant clinical understanding of the treatment of immune diseases and a strong passion to drive development into diverse indications, based on scientific rationale and unmet medical needs
• Broad understanding of drug development is critical with ability to drive innovation in drug development and ability to supervise, lead through delegation, and implement and maintain high standards of research conduct
• Exceptional communication skills and leadership experience in clinical development to communicate goals and deliverables to senior management and governance committees through J&J

ImpactImm

Primary Location
United States-Pennsylvania-Spring House-
Organization
Janssen Research & Development, LLC (6084)
Job Function
R&D
Requisition ID
7940200206

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